(153 days)
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are bench tests of mechanical properties.
Yes.
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which constitutes a therapeutic purpose.
No
The provided text describes a "Perfix™ Spinal System" and "Perfix™ Iliac Screw System," which are devices intended for immobilization and stabilization of spinal segments as an adjunct to fusion. These are implants used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the Perfix™ Iliac Screw System consists of physical implant components made from titanium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Perfix™ Spinal System and Iliac Screw System are implantable devices used for spinal fixation and stabilization in the thoracic, lumbar, and sacral spine. They are used as an adjunct to fusion by bone graft.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any diagnostic tests. The testing described is bench testing on the device itself to assess its mechanical properties.
Therefore, the Perfix™ Spinal System and Iliac Screw System are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Spondylolisthesis (Grade 3 and 4) .
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis .
- Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
- Pelvic obliquity ●
- Spinal tumor
- Pseudarthrosis
- Failed previous fusion
The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.
Product codes
MNH, MNI, KWP
Device Description
Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine and sacrum regions, thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Perfix™ Iliac Screw System was tested in a non clinical setting (bench testing) to assess that to know new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Perfix™ Iliac Screw System is substantially equivalent to the predicate devices.
The following tests were performed:
-
- Construct Test (ASTM F1717)
- (1) Static compression bending test
- (2) Static torsion test
- (3) Dynamic compression bending test
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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K132218 - Page 1 of 3
DEC 1 7 2013
Manufacturer: U & I Corporation 20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do, Korea, 480-859 Sponsor: U & I Corporation 20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do, Korea, 480-859 Sponsor Contact: Young-Geun, Kim, Regulatory Affairs Assistant +82 31 852 0102 (ext.619) ygkim@youic.com Dec 17, 2013 Date Prepared: Trade Name: Perfix™ Iliac Screw System Device Name: Spinal Fixation System, per 21 CFR 888.3050 and 888.3070 Classification Name: Spinal Fixation System Common Name: Product Code: MNH, MNI, KWP Synergy™ Spinal System – Synergy VLS Screws (K011437) Predicate Devices: OPTIMA™ Spinal System (K024096) Global Spinal Fixation System™ (K001668)
Perfix™ Iliac Screw System
510(k) Summary
1
Description of Device:
Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.
Intended Use:
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Spondylolisthesis (Grade 3 and 4) .
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis .
- Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
- Pelvic obliquity ●
- Spinal tumor
- Pseudarthrosis
- Failed previous fusion
The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.
Substantial Equivalence:
The Perfix™ Iliac Screw System is substantially equivalent to Synergy "" Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096) and Global Spinal Fixation System™ (K001668) in design, material, mechanical performance, function and intended use.
The mechanical performance of Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices.
Perfix™ Iliac Screw System
CORPORATION
2
1. Comparison Technological Characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;
- The similar indications for use .
- Similar design features
- Incorporate the same or similar materials
- The equivalent mechanical performance
2. Performance Testing
The Perfix™ Iliac Screw System was tested in a non clinical setting (bench testing) to assess that to know new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Perfix™ Iliac Screw System is substantially equivalent to the predicate devices.
The following tests were performed:
-
- Construct Test (ASTM F1717)
- (1) Static compression bending test
- (2) Static torsion test
- (3) Dynamic compression bending test
3. Conclusion
The data and information provided in this submission support the conclusion that the Perfix™ Iliac Screw System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
U&i CORPORATION
Perfix™ Iliac Screw System
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2013
U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Assistant 20. Sandan-ro. 76beon-gil (Rd) Uijeongbu-si, Gyeonggi-do Republic of Korea 480-859
Re: K132218
Trade/Device Name: Perfix™ Iliac Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNH, KWP Dated: November 14, 2013 Received: November 15, 2013
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Young-Geun Kim
forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MédicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
RonaldFP: Jean -S for
- Mark N: Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
K132218 510(k) Number (if known):
Device Name: Perfix™ Iliac Screw System
Indications for Use:
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Spondvlolisthesis (Grade 3 and 4) .
- Degenerative spondylolisthesis with objective evidence of neurological . impairment
- Trauma (i.e., fracture or dislocation) ●
- Spinal stenosis œ
- Spinal deformities (Scoliosis, Kyphosis, Lordosis)
- Pelvic obliquity
- Spinal tumor
- Pseudarthrosis
- Failed previous fusion
The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, illiac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zane W. Wyatt -S
(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K132218 Perfix™ illiac Screw System
U&i CORPORATION